Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2921595

FEI Number

2921595

Entity Name

Sterngold Dental LLC

City/State/Country

Attleboro, MA, US

Establishment Address

23 Frank Mossberg Drive, Attleboro, MA 02703, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Sterngold (Owner Number: 10023675)

Owner / Operator Contact Address

23 Frank Mossberg Drive, Attleboro, MA 02703, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K981516

PMA Number

N/A

All Registered Proprietary Names

Sterngold G-Hard Stern ERA Resilient Dental System Implamed Implant System Implamed Hex Screw Implants, 18mm and 20mm ERA Implant Stern ERA Alignment Correction Implant Abutment Implamed Hex Screw Implants, 4.5mm and 6mm Diameter ERA Pickup Mixing Tips Stern Vantage SternTek Custom Tray Impression Material Stern Tek Duplicating Material Instatemp Max Stern Root Anchor System Tempolock Titanium & Stainless Steel Instruments Screw Drivers, Hex Drivers, Seating Tools, Implant Mount, Depth Probe, Ratchet Wr Sterngold Dental Narrow Platform Dental Implants, Related Prosthetics & Instruments ERA Dental Implant System Sterngold Dental Instruments Sterngold Dental Accessories SFI Abutments Platforms BD BE BF AE AN AP AY AJ AK Implamed Implant System Criterion Stern Vantage Acid Etch Implant System Sterngold Bio-H & Bio-C Stern Snap 0 Degree Attachment SternOmega Sern IC Dental Implant System Pegasus Phoenix & 2713 Pegasus Dental Alloy 3340109 Blue Friction Sleeves 3340108 TDI Yellow Pins 3340104 Red Friction Sleeves Implamed UCLA Type Abutments and Accessories PUR Dental Implant System Titanium & Stainless Steel Dental Implant Drill, Countersinks, Bone Taps, Marking burs MOR Dental Implant System MOR 3mm and PUR 3.2mm Implant Systems, Mor 2.1x18mm and MOR 2.4x18mm Implants Omegaflo Sterngold Bio-4 EZ Pickup Material Instatemp Max Sterngold Implamed Hex Screw Implant TPS and HA Coated Stern Omega Micro ERA System Stern 1 Galaxy Stern AC Dental Implant System Implamed Low Margin Abutments Apollo Stern Vantage Sterngold Implamed Hex Screw Implant TPS and HA Coated

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJS	Alloy, Other Noble Metal	Dental	Class 2	872.3060	2009-02-04
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-02-04
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-02-04
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-02-04
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-02-04
EJT	Alloy, Gold-Based Noble Metal	Dental	Class 2	872.3060	2017-03-09
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-02-04
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-02-04
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2014-01-10
ELW	Material, Impression	Dental	Class 2	872.3660	2009-02-04
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2011-11-17
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2009-02-04
ELR	Post, Root Canal	Dental	Class 1	872.3810	2009-02-04
EMA	Cement, Dental	Dental	Class 2	872.3275	2009-02-04
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-02-04
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-02-04
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-02-04
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2011-11-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2014-05-08
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-02-04
EJT	Alloy, Gold-Based Noble Metal	Dental	Class 2	872.3060	2009-02-04
ELW	Material, Impression	Dental	Class 2	872.3660	2009-02-04
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-02-04
EJT	Alloy, Gold-Based Noble Metal	Dental	Class 2	872.3060	2009-02-04
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2015-01-15
EMA	Cement, Dental	Dental	Class 2	872.3275	2009-02-04
EMA	Cement, Dental	Dental	Class 2	872.3275	2021-12-09
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2012-10-22
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2012-10-22
EJT	Alloy, Gold-Based Noble Metal	Dental	Class 2	872.3060	2009-02-04
EJS	Alloy, Other Noble Metal	Dental	Class 2	872.3060	2009-02-04
EJT	Alloy, Gold-Based Noble Metal	Dental	Class 2	872.3060	2013-08-12
EGG	Attachment, Precision, All	Dental	Class 1	872.3165	2015-02-02
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-02-04
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2015-11-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-02-04
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-03-01
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-03-01
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-10-09
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-10-09
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2009-02-04
EJS	Alloy, Other Noble Metal	Dental	Class 2	872.3060	2009-02-04
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2009-02-04
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-02-04
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2009-02-04
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-02-04
EJS	Alloy, Other Noble Metal	Dental	Class 2	872.3060	2009-02-04
EJT	Alloy, Gold-Based Noble Metal	Dental	Class 2	872.3060	2009-02-04
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2015-01-15
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-02-04
EJT	Alloy, Gold-Based Noble Metal	Dental	Class 2	872.3060	2009-02-04
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2009-02-04
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-02-04

Official Correspondent

Laura Greige

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sterngold

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14
K903999	O Co., Inc.	OBUTMENT HB	1992-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Z-0029-05	Implant Innovations, Inc.	2	EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2921595. Last updated year: 2026. Please use registration number 2921595 when referencing this establishment in official correspondence.